FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEADLAMP HL2000.
K Number: K994362
·
Decision May 11, 2000
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
3
Applicant Total
10
Review Days
136
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Basic Information
- Device Name
- HEADLAMP HL2000.
- K Number
- K994362
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4335
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Angiolaz, Inc.
- Date Received
- December 27, 1999
- Decision Date
- May 11, 2000
- Product Code
- FSR
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FSR | Light, Headband, Surgical | FDA class 2 | Ophthalmic |
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Other Clearances by Angiolaz, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992447 | 50 W METAL HALIDE ILLUMINATOR, VES 0501. | Oct 20, 1999 | Substantially Equivalent |
| K982397 | VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM | Sep 10, 1998 | Substantially Equivalent |
| K982409 | VES 1501-M | Aug 21, 1998 | Substantially Equivalent |
| K981819 | ANGIOLAZ VES-1CAM | Aug 4, 1998 | Substantially Equivalent |
| K981821 | VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR | Jul 29, 1998 | Substantially Equivalent |
| K981827 | VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM | Jul 28, 1998 | Substantially Equivalent |
| K933868 | ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES | Nov 10, 1993 | Substantially Equivalent |
| K913129 | ANGIOLAZ ANGIOSCOPE CATHETER | Dec 27, 1991 | Substantially Equivalent |
| K902329 | ULTRA-VU ANGIOSCOPE | Aug 22, 1990 | Substantially Equivalent |